5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors

Well differentiated neuroendocrine carcinomas have low proliferative activity and conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent administration of cytotoxic drugs at low doses, has demonstrated antiangiogenetic properties. Since well differentiated NE carcinomas are highly vascular, there is a rationale for testing metronomic chemotherapy in this clinical setting.

A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU) infusion plus long-acting release (LAR) octreotide for patients with neuroendocrine carcinoma.

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Key information

Conditions

Neuroendocrine Tumors Adenocarcinoma Carcinoma Carcinoma, Neuroendocrine Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federico Castiglione, Alba, Cuneo, Italy

About this study

Metastatic or locally advanced well differentiated neuroendocrine carcinoma were treated with 5Fluorouracil protracted intravenous infusion (200 mg/m2 daily) plus Octreotide LAR (20 mg monthly).

Primary Endpoint: the response to treatment, evaluated according to the RECIST criteria.

Secondary Endpoints:

toxicity, graded according to the NCI-CTG criteria;
symptomatic response: evaluated according to the changes in both the frequency and intensity of symptoms;
biochemical response: evaluated considering the changes in the tumor marker levels (circulating Chromogranin A);
time to progression and survival: were measured from the date of treatment start to the date of progression and the date of last follow-up or death, respectively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

histological diagnosis of well-differentiated neuroendocrine carcinoma according to the World Health Organization (WHO) classification;
locally advanced or metastatic disease not amenable to surgery with radical intent;
at least one measurable target lesion;
radiological documentation of progressive disease;
ECOG performance status grade <=2;
life expectancy >12 weeks;
adequate bone marrow reserve;
adequate hepatic and renal function;
ability to comply with the protocol procedures (including geographic accessibility);
written informed consent.

Exclusion criteria

non-malignant systemic disease or conditions that precluded patients from receiving the study therapy;
second primary malignancies and previous systemic antineoplastic treatment including somatostatin analogues;
history of prior malignancy, excepted for cured non-melanoma skin cancer, and cured in situ cervical carcinoma.

Treatment and study plan

continuous 5 fluouracil infusion plus long-acting octreotide

Drug

long-acting octreotide acetate at a dose of 20 mg was administered intramuscularly every 4 weeks. 5fluorouracil was given as a protracted continuous infusion without interruption at a daily dose of 200 mg/m2 of body-surface area through an elastomeric pump connected to a central venous access.

Other names: metronomic 5 fluouracil infusion plus long-acting octreotide

Primary outcomes

disease free survival

Time frame: 50 months

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Continuous 5-fluorouracil Infusion Plus Long Acting Octreotide in Advanced Well Differentiated Neuroendocrine Carcinomas. A Phase II Trial of the Piemonte Oncology Network.

Important dates

Study start: 2002
Primary completion: 2006
Study completion: 2006
First posted: Aug 6, 2009
Registry last updated: Aug 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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